GCI — Laryngoscope, Endoscope Class II
FDA product code GCI covers "Laryngoscope, Endoscope", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GCI
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K021747 | surgicon | DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR | August 15, 2002 |
| K003222 | computer motion | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER | November 3, 2000 |
| K001362 | karl storz imaging | KARL STORZ 3D VIDEO SYSTEM | July 17, 2000 |
| K933515 | t-med | BOOTY ENDOSCOPE WARMER | October 27, 1993 |
| K930302 | birtcher medical systems | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM | October 27, 1993 |
| K930496 | birtcher medical systems | GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS | April 20, 1993 |
| K922123 | united states surgical, a division of tyco healthc | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH | February 1, 1993 |
| K920139 | conmedcorp | GLEESON CLOT-BUSTER | April 15, 1992 |
| K915762 | o.r. concepts | POOLE TIP SUCTION PROBE | March 13, 1992 |
| K914120 | conmedcorp | SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT | October 30, 1991 |
| K911829 | ethicon | ENDOSTAPLE | August 28, 1991 |
| K905117 | northgate technologies | ENDOSCOPE AND ACCESSORIES | April 25, 1991 |
| K911461 | ellman intl. mfg | SURGITRON | April 25, 1991 |
| K896205 | dexide | MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE | March 22, 1990 |